Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease

Cardiovascular Disease Clinical Trial

Official title:

Exercise Therapy for Abdominal Aortic Aneurysm Disease: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234610
• Other study ID #: STH15455
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: December 18, 2017
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2017
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta, which is a large blood vessel in the abdomen. Large AAAs (>55 mm diameter) carry a high risk of rupture, a surgical emergency that often leads to death due to severe internal bleeding. It has been suggested that regular exercise training might limit the rate at which AAAs develop. However, little is known about the safety and effectiveness of exercise training in these patients. This pilot study will examine the feasibility of supervised aerobic exercise training for patients with small AAAs (30 to 49 mm diameter). The investigators hypothesize that exercise training will be safe and useful for patients with small AAAs.

Description:

Abdominal aortic aneurysm (AAA) disease is a potentially lethal health problem of older adults. New screening initiatives will identify many individuals with small (30 to 49 mm) AAAs for which there are currently no treatment options. Regular aerobic exercise might retard AAA disease progression, but the feasibility and acceptability of aerobic exercise in patients with AAA disease has yet to be established. This pilot study will examine the feasibility of supervised aerobic exercise and exercise advice-only in patients with small AAAs. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the supervised exercise programme will be offered three supervised cycle ergometry/treadmill-walking sessions for a period of 12 weeks. The feasibility of each intervention will be assessed in terms of recruitment and compliance, attrition, changes in cardiopulmonary fitness and objective measures of free-living physical activity. Changes in aneurysm size and blood markers associated with disease progression will also be monitored and the impact of the interventions on health-related quality of life assessed using a questionnaire. Outcomes will be assessed at baseline and 12 weeks. We will also conduct focus groups at the end of the trial to obtain qualitative feedback from patients. The results of this study will inform the design of a multi-centre randomised controlled trial with longer-term follow-up of clinical end-points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Men or women identified as having a stable 30 to 49 mm asymptomatic, infra-renal AAA, measured using high-resolution B-mode ultrasonography

• Ability to undertake exercise testing and training

Exclusion Criteria:

• Patients with large (>50 mm)/symptomatic AAAs

• Patients with contraindications to exercise testing/training (e.g. severe hypertension, unstable metabolic/cardiopulmonary conditions, musculoskeletal injuries etc…)

• Patients who are unable to travel to the testing and training facility at Sheffield Hallam University

• Patients who are already participating in regular exercise

• Patients with a mental impairment that would render consent unethical or would make compliance difficult (e.g. dementia or Alzheimer's)

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Disease
• Aortic Diseases
• Cardiovascular Disease
• Cardiovascular Diseases
• Vascular Disease
• Vascular Diseases

Intervention

Behavioral:
• Supervised exercise training
Patients will be asked to attend three exercise sessions per week for 12 weeks. They will exercise in groups of up to four per session and they will be supervised by an experienced exercise physiologist. Each session will comprise 5 to 10 min warm-up period (involving very light aerobic exercise and a range of gentle movements), 30 min of light-to-moderate intensity aerobic exercise (cycle-ergometry and or treadmill-walking), and a 5 to 10 min cool-down period involving low-intensity aerobic exercise and gentle stretching. The intensity of the aerobic exercise will be individualised and will be progressed gradually (if appropriate) during the course of the study.

Locations

Country	Name	City	State
United Kingdom	Sheffield Hallam University	Sheffield	South Yorkshire
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield Hallam University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	We will monitor how feasible it is to recruit, test and train patients with small AAAs	12 weeks
Secondary	Cardiopulmonary fitness	Peak oxygen uptake and ventilatory threshold assessed during an incremental-load cycling test	12 weeks
Secondary	Quality of life	Health-related quality of life assessed using the MOS SF-36 v2 questionaire	12 weeks
Secondary	Aneurysm size	Aneurysm size as measured using B-mode ultrasound	12 weeks
Secondary	Blood biomarker of disease progression	Fasting blood samples will be taken to assess changes in hs-CRP	12 weeks
Secondary	Blood biomarker of disease progression	Fasting blood samples will be taken to assess changes in MMP-9	12 weeks